Treatment (ProudMe)ProudMeNCT06335056
Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
A study testing ProudMe in people with Treatment (ProudMe) and Waitlist Control, run by Louisiana State University and A&M College at 1 site in United States.
Trial summary
This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention… Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment (ProudMe), Waitlist Control
- What is being tested?
- ProudMe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in 6th, 7th, or 8th grades in participating schools.
- Students with parental consent and child assent.
Who cannot join
- Students enrolled in grades other than 6th, 7th, or 8th grades
- Students in non-participating schools.
- Students without parental consent and child assent.
- Students without adequate readiness for physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Pedagogical Kinesiology Lab
Baton Rouge, Louisiana, 70803
About this study
This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.
Read the detailed description
The Louisiana-based, 12-week, multi-level, multi-component, ecological intervention is called Preventing Obesity Using Digital-assisted Movement and Eating (ProudMe). Guided by robust theories and prior work, this project involves multiple trained student researchers to address two specific aims.
Aim 1: to test the effectiveness of the ProudMe intervention in Louisiana middle schools. Informed by power analysis (80% statistical power), the study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools). Quantitative data on obesity-prevention behaviors (i.e., physical activity, screen-based sedentary behavior, diet behaviors) and weight status (i.e., body mass index z score, waist circumference) are collected from all adolescent participants using validated instruments and procedures. The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control, after controlling for sociodemographic factors at multiple ecological levels.
Aim 2: to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools. The investigators collect mixed-methods data from 24 school implementers (i.e., teachers, administrators, and staff), 96 adolescents, and 96 parents at the 6 ProudMe schools, to capture adaptation and implementation indicators. The investigators evaluate the adaptations made across three phases (early, mid, late) of the implementation (i.e., what, at what level, when, how, why, by whom, and impact to intervention). In addition, the investigators assess reach, fidelity, penetration, sustainability, and cost of the implementation across early, mid, and late phases of the implementation. The investigators expect the ProudMe schools to show appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.
Building on previously funded work (e.g., R21HD090513, PI: Dr. Chen), this project is led by a strong, collaborative, transdisciplinary team with experts from kinesiology, developmental psychology, nutrition, childhood obesity, computer science, statistics, and implementation science. The project significantly strengthens the research environment of the Louisiana State University (LSU) - a primarily undergraduate student serving institution under-funded by the NIH. The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields.
- Conditions
- Treatment (ProudMe), Waitlist Control
- Being tested
- ProudMe, Waitlist Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProudMeBehavioural
ProudMe Tech: Regular human/computer interaction (3-5 times per week) to engage in SMART goal-setting, behavior monitoring, and self-reflection as assisted by AI-enabled feedback.
ProudMe Physical Education [PE]: 12 lessons to acquire knowledge, skill, and dispositions to improve physical activity, diet, screen-based sedentary behaviors.
ProudMe Cafeteria: Purposely enabling policy and environmental changes in school cafeteria (recognize areas of strengths and weaknesses; set goals and action plans; make changes to improve scores assessed by the Smarter Lunchroom Scorecard).
ProudMe Training: 4-hour implementation training + regular check-in and support (via motivational interviewing techniques)
Waitlist ControlBehavioural
The waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the overall importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system.
| Study group | Role | What they receive |
|---|---|---|
| ProudMe | Experimental | The ProudMe condition involves three key components: (a) artificial intelligence (AI)-assisted behavior management system (i.e., ProudMe Tech), (b) ProudMe physical/health education (PE) and lunchroom reform (ProudMe Cafeteria), (c) customized implementation training (ProudMe Training). Receives: Behavioral: ProudMe |
| Waitlist Control | Active comparator | The waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system. Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers
Self-reported screen time
Measured: 12 weeks
Screen time
a screen time questionnaire
Measured: 12 weeks
Food environment
Parent-reported Food Frequency Questionnaire
Measured: 12 weeks
Secondary outcomes (2)
Body mass index z score
Body mass index (BMI) z scores and BMI scores are converted by weight and height. Body weight is measured to the nearest 0.1kg with a calibrated Seca Model 770 scale. Raw BMI score is calculated from height and body weight as follows: BMI (kg/m2) = Body weight (kg) / Height (m)2. BMI-z score is calculated to examine how many standard deviations adolescents' BMI is above or below the average BMI value for their age group and gender.
Measured: 12 weeks
Waist circumference
Waist circumference at the umbilicus is assessed to the nearest 0.5cm using a constant tension tape.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start19 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment (ProudMe)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pennington Biomedical Research Center, Texas A&M University, University of Nevada, Las Vegas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335056
- Sponsor's protocol ID
- IRBAM-21-0702
- Other IDs
- 1R15HD108765-01A1
- Acronym
- ProudMe
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
- ClinicalTrials.gov ID
- NCT06335056
- Acronym / sponsor ID
- ProudMe / IRBAM-21-0702
- Conditions
- Treatment (ProudMe), Waitlist Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Pennington Biomedical Research Center, Texas A&M University, University of Nevada, Las Vegas
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.
Detailed description
The Louisiana-based, 12-week, multi-level, multi-component, ecological intervention is called Preventing Obesity Using Digital-assisted Movement and Eating (ProudMe). Guided by robust theories and prior work, this project involves multiple trained student researchers to address two specific aims.
Aim 1: to test the effectiveness of the ProudMe intervention in Louisiana middle schools. Informed by power analysis (80% statistical power), the study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools). Quantitative data on obesity-prevention behaviors (i.e., physical activity, screen-based sedentary behavior, diet behaviors) and weight status (i.e., body mass index z score, waist circumference) are collected from all adolescent participants using validated instruments and procedures. The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control, after controlling for sociodemographic factors at multiple ecological levels.
Aim 2: to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools. The investigators collect mixed-methods data from 24 school implementers (i.e., teachers, administrators, and staff), 96 adolescents, and 96 parents at the 6 ProudMe schools, to capture adaptation and implementation indicators. The investigators evaluate the adaptations made across three phases (early, mid, late) of the implementation (i.e., what, at what level, when, how, why, by whom, and impact to intervention). In addition, the investigators assess reach, fidelity, penetration, sustainability, and cost of the implementation across early, mid, and late phases of the implementation. The investigators expect the ProudMe schools to show appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.
Building on previously funded work (e.g., R21HD090513, PI: Dr. Chen), this project is led by a strong, collaborative, transdisciplinary team with experts from kinesiology, developmental psychology, nutrition, childhood obesity, computer science, statistics, and implementation science. The project significantly strengthens the research environment of the Louisiana State University (LSU) - a primarily undergraduate student serving institution under-funded by the NIH. The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions.
| Arm | Type | Receives |
|---|---|---|
| ProudMe | Experimental | Behavioral: ProudMeThe ProudMe condition involves three key components: (a) artificial intelligence (AI)-assisted behavior management system (i.e., ProudMe Tech), (b) ProudMe physical/health education (PE) and lunchroom reform (ProudMe Cafeteria), (c) customized implementation training (ProudMe Training). |
| Waitlist Control | Active comparator | Behavioral: Waitlist ControlThe waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students enrolled in 6th, 7th, or 8th grades in participating schools.
- Students with parental consent and child assent.
Key exclusion criteria (4 listed)
- Students enrolled in grades other than 6th, 7th, or 8th grades
- Students in non-participating schools.
- Students without parental consent and child assent.
- Students without adequate readiness for physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProudMeProudMe Tech: Regular human/computer interaction (3-5 times per week) to engage in SMART goal-setting, behavior monitoring, and self-reflection as assisted by AI-enabled feedback. ProudMe Physical Education [PE]: 12 lessons to acquire knowledge, skill, and dispositions to improve physical activity, diet, screen-based sedentary behaviors. ProudMe Cafeteria: Purposely enabling policy and environmental changes in school cafeteria (recognize areas of strengths and weaknesses; set goals and action plans; make changes to improve scores assessed by the Smarter Lunchroom Scorecard). ProudMe Training: 4-hour implementation training + regular check-in and support (via motivational interviewing techniques) | Behavioural | ProudMe |
| Waitlist ControlThe waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the overall importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system. | Behavioural | Waitlist Control |
Primary outcome
Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers
Time frame: 12 weeks
Self-reported screen time
Screen time
Time frame: 12 weeks
a screen time questionnaire
Food environment
Time frame: 12 weeks
Parent-reported Food Frequency Questionnaire
2 secondary outcomes
Body mass index z score
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProudMe in people with Treatment (ProudMe) and Waitlist Control, run by Louisiana State University and A&M College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.